BEUDAMED
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    AR-1600 AUTOMATIC REFRACTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NR Recorder

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HISTO-TEK W/ AUTOMATIC COVERSLIPPER

    FDA 510(k)
    FDA Class 1 ·Pathology

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·April 14, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 3, 2012

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·October 7, 2010

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012